September 1, 2014
Centers for Medicare and Medicaid Services Department of Health and Human Services Attention: CMS-1614-P
Baltimore, MD 21244-8010
A teaching affiliate of Harvard Medical School
Re: Comment advising against reclassifying Auditory Osseointegrated Implants as hearing aids, and thus advising against elimination of Medicare benefits for the surgical implantation and use of these devices (CMS- 1614-P)
I am writing to request strongly that Medicare benefits be maintained for the Auditory Osseointegrated Implant (AOI). I am a licensed audiologist in the Commonwealth of Massachusetts and hold Board Certification in Audiology and the Certificate of Clinical Competence in Audiology (CCC-A). I have 42 years of experience as a clinical audiologist. I currently serve as Director of Habilitative Audiology at Boston Children’s Hospital and Assistant Professor of Otology and Laryngology at Harvard Medical School. I am interested in the challenges faced by policymakers who seek scientific evidence and human impact of policy changes, and have given presentations to students to help them interpret and design future studies to yield data useful not only to guide clinical practice but also to guide policymakers. I have no financial interest and no current advisory capacity for any manufacturer, although I served on a scientific advisory board for a cochlear implant manufacturer in the past. Most of my clinical work now focuses on cochlear implant candidates and recipients, although I have provided and observed care for many patients over the years whose hearing loss was not well served by hearing aids but did fall in the range of candidacy for the AOI. I have grave concern that a particular subgroup of the population of individuals with hearing loss will be discriminated against because no air or bone conduction hearing aid provides usable hearing correction that is adequate for consistent access to spoken communication, while the surgical option of the AOI will be out of reach for them financially.
The reason given in CMS-1614-P for eliminating coverage for the AOI is that it is not a prosthetic device. The cochlear implant and auditory brainstem implant are considered to be “prosthetic devices...(that) replace all or part of an internal body organ.” However, one can define organ parts in various ways. Cochlear implant electrodes stimulate spiral ganglion cells, which are the nerve cell bodies of the auditory nerve. These spiral ganglion cells are in the core of the cochlea, a structure in which the implant is placed, not which is replaced. An AOI stimulates the cochlea by vibrating the mastoid bone without partial loss of signal through soft tissue, when the outer or middle ear part of the hearing organ is not functioning to carry the signal to the cochlea in the usual manner. A device analogous to the AOI currently is covered by Medicare as a prosthesis: replacement of the lens of the eye. The lens is not the sensory organ of the eye but rather a focusing element to present the signal properly to the retina, much as the AOI presents the signal to the organ of Corti in the cochlea. The external specially-fitted eyeglass lens to use with the new intraocular lens also is covered (minus any correction for presbyopia), analogous to the externally worn processor of the AOI.
It is not the coverage of the AOI that needs revision, but rather the definitions within categories of Prostheses, Orthotics and Durable Medical Equipment that may need revision in the direction of “intent” to meet the growing number of surgical interventions that require internal or external devices in order to function. Medicare coverage should provide access to such an intervention when it is necessary because the individual in question would not be served adequately by a non-surgical option. Review of existing studies of the auditory outcome and quality-of-life benefit of the Auditory Osseointegrated Implant, compared to bone conduction hearing aids or external auditory canal reconstruction, supports the need for coverage for the AOI to continue, both for existing users and candidates. Additional outcome data should continue to be gathered to refine the prediction of benefit for the surgical versus non-surgical options for potential candidate subgroups.
Thank you for consideration of this viewpoint, on behalf of the current and future needs of our patients. Sincerely,
Marilyn Neault, PhD, CCC-A
August 4, 2014
Centers for Medicare and Medicaid Services
Department of Health and Human Services
PO Box 8013
Baltimore, MD 21244-1850
Dear CMS Administrator Tavenner:
I have recently learned about CMS’s proposal to modify the existing regulation §411.15(d)(1). I understand that this will ensure that the hearing aid exclusion encompasses all types of air conduction and bone conduction hearing aids (external, internal, or implanted). Therefore, this would suggest no coverage for individuals currently using osseointegrated devices and those who are in need of osseointegrated devices. I am writing in the hopes that this decision will be overturned
I am a practicing audiologist at Trinity Hospital in Minot, ND. I began my career working with children who have hearing loss at St. Louis Children’s Hospital for approximately four years. I then moved to my hometown of Minot, ND and have been practicing for the last four years within an Ear, Nose, and Throat (ENT) department alongside 2 ENT physicians and another audiologist. We all serve patients birth to adult and therefore serve the local Medicare population. We provide diagnostic services to assess the ear and diagnose hearing loss, provide initial and post-surgical testing and programming of cochlear implants and osseointegrated devices, and dispense and program hearing aids.
I am highly concerned about this proposed decision as it will significantly negatively affect the population we serve. There are a number of patients whose hearing loss and/or anatomy prohibits them from use of hearing aids. The auditory osseointegrated implant and other prosthetic devices are fundamentally different from hearing aids. This proposal will result in individuals having no access to sound, which results in them having no access to communication (as it will be very unlikely they and their families will be able to become fluent sign language users). They will not have the ability to hear alarms ensuring safety; they will be unable to converse on the phone should they need to call for an emergency or otherwise. Their ability to function as a member of a community will be taken away. First, this will increase the patient’s depression. I have had numerous patients return after being fitted telling me they had no idea how much they had isolated themselves from family and friends. They reported to me that it was too much work and they did not understand what was going on, so they stopped participating in life. One woman in particular shared that she finally has friends again; that she is able to meet with people for coffee and lunch and doesn’t feel alone anymore. In addition to causing depression, untreated hearing loss has also been linked to an increase in dementia. There are numerous studies that have shown this and continue to document this.
The fact of the matter is: an osseointegrated device IS A SURGICALLY IMPLANTED PROSTHETIC, not a hearing aid. Because it is a surgical option, thorough evaluation is completed by audiologists and physicians who have experience with these devices. Patients who qualify for this surgery and device are candidates because hearing aids have not been successful or are not an option for the individual.
I challenge you to wear earplugs and earmuffs together for just one day. See what it is like to have your ability to communicate, work, and socialize taken away for just one day. Hearing is a critical sense, and individuals with limitations in this sense should not be left without help when there is proven treatments available.
I thank you for your time and attention. I sincerely hope that you will listen to what I’ve written and think about how this would impact your life or a family member’s life. If you can do that, you will easily see that a re-evaluation of this proposal should be made. The patients who only have osseointegrated devices as their option to continue as a functioning member of our community should not be left without that treatment.
Jerrica Leigh Maxson, AuD
101 3rd Avenue SW, Suite 203
Minot, ND 58702